Cardiac DiseaseNCT04804969
MyoVista wavECG Clinical Validation Study Versus Low e' on Echocardiogram
An observational study of Cardiac Disease, run by Heart Test Laboratories, Inc. at 5 sites in United States.
Trial summary
Clinical validation study of the MyoVista wavECG. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Cardiac Disease
- What is being tested?
- MyoVista wavECG Test
- Type of treatment
- Medical device
- How many people
- 575 participants
- Where
- 5 sitesUnited States
- Study dates
- 10 May 2021to 30 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects with risk factors for cardiac disease or suspected of having cardiac disease during clinical assessment and have been referred to the site for 2D transthoracic echocardiogram.
Who may be able to join
- Subjects with risk factors for cardiac disease or suspected of having cardiac disease during clinical assessment.
- The subject provides written informed consent using an Informed Consent Form that is reviewed and approved by the site's Institutional Review Board (IRB).
- Conventional ECG results show a sinus rhythm and no other contraindicated rhythm abnormalities (see exclusions below).
- Subject is >/= 22 years of age
Who cannot join
- The subject has current acute coronary syndrome, decompensated heart failure or stroke
- The subject has received any prior cardiac interventions or surgical therapeutic procedures relating to cardiac abnormalities: valve replacement, pacemaker implantation, coronary artery bypass grafting (CABG), heart transplant, ablation, coronary stent placement, etc.
- Conventional ECG results indicating a lack of sinus rhythm and/or any other contraindicated rhythm abnormalities, including: active atrial fibrillation or atrial flutter, left anterior fascicular block, left and/or right bundle branch block
- The subject is pregnant at the time of the study testing
- The subject has chest deformities that interfere with accurate measurement of ECG (either conventional or wavECG)
- Subjects with central nervous system or musculoskeletal abnormalities that may interfere with accurate acquisition of ECG and/or echocardiogram measurements.
- The subject is enrolled in another clinical study that may interfere with MyoVista or echocardiogram measurements. Exceptions to this may be approved by HeartSciences.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
University of Texas Southwestern Medical Center
Dallas, Texas, 75204
Scripps Memorial Hospital
La Jolla, California, 92037
Einstein Medical Center
Philadelphia, Pennsylvania, 19141
Montefiore Medical Center
The Bronx, New York, 10467
About this study
Official title: MyoVista wavECG Clinical Validation Study
Clinical validation study of the MyoVista wavECG.
Read the detailed description
This is a multi-center, non-interventional, single arm clinical study of the MyoVista wavECG for the detection of LV relaxation abnormalities. Study subjects will be drawn from patients who are at-risk for cardiac disease and who have been referred for 2D transthoracic echocardiogram.
The study will be conducted at a minimum of three investigational sites within the United States.
- Conditions
- Cardiac Disease
- Being tested
- MyoVista wavECG Test
- Keywords
- Left Ventricular Diastolic Dysfunction, Electrocardiograph
- Medical subject headings
- Heart Diseases, Ventricular Dysfunction, Left
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MyoVista wavECG TestDevice
The MyoVista wavECG is a standard 12-Lead high-performance, multi-channel resting interpretive electrocardiograph providing both a Glasgow Interpretive Analysis and unique MyoVista wavECG Information.
| Study group | Role | What they receive |
|---|---|---|
| At Risk Echo Referrals | Study subjects will be drawn from patients who are at-risk for cardiac disease and who have been referred for 2D transthoracic echocardiogram as standard of care. All will receive a MyoVista wavECG test. Receives: Device: MyoVista wavECG Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and Specificity
Sensitivity and specificity of the MyoVista for the classification of Low e' from echocardiogram where a "positive" includes Positive and Highly Positive MyoVista Device outcomes.
Measured: Baseline
Secondary outcomes (1)
Sensitivity and Specificity
Sensitivity and specificity of the MyoVista for classification of Low e' versus echocardiogram where a "positive" includes Borderline, Positive and Highly Positive MyoVista Device outcomes.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2021
- Study start10 May 2021
- Primary completion30 Nov 2023 (estimated)
- Study completion30 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 575 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heart Test Laboratories, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Partho Sengupta, MD, Principal investigator, Robert Wood Johnson University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04804969
- Sponsor's protocol ID
- HS-CLINVAL-001
- Status last verified
- Sep 2023
- First submitted
- 16 Mar 2021
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MyoVista wavECG Clinical Validation Study
- ClinicalTrials.gov ID
- NCT04804969
- Acronym / sponsor ID
- HS-CLINVAL-001
- Conditions
- Cardiac Disease
- Keywords
- Left Ventricular Diastolic Dysfunction, Electrocardiograph
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 575 participants (actual)
- Lead sponsor
- Heart Test Laboratories, Inc.Industry (pharma, biotech, devices)
- Study start
- 10 May 2021 (actual)
- Primary completion
- 30 Nov 2023 (estimated)
- Study completion
- 30 Nov 2023 (estimated)
- First posted
- 18 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Clinical validation study of the MyoVista wavECG.
Detailed description
This is a multi-center, non-interventional, single arm clinical study of the MyoVista wavECG for the detection of LV relaxation abnormalities. Study subjects will be drawn from patients who are at-risk for cardiac disease and who have been referred for 2D transthoracic echocardiogram.
The study will be conducted at a minimum of three investigational sites within the United States.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| At Risk Echo Referrals | – | Device: MyoVista wavECG TestStudy subjects will be drawn from patients who are at-risk for cardiac disease and who have been referred for 2D transthoracic echocardiogram as standard of care. All will receive a MyoVista wavECG test. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with risk factors for cardiac disease or suspected of having cardiac disease during clinical assessment and have been referred to the site for 2D transthoracic echocardiogram.
Key inclusion criteria (4 listed)
- Subjects with risk factors for cardiac disease or suspected of having cardiac disease during clinical assessment.
- The subject provides written informed consent using an Informed Consent Form that is reviewed and approved by the site's Institutional Review Board (IRB).
- Conventional ECG results show a sinus rhythm and no other contraindicated rhythm abnormalities (see exclusions below).
- Subject is >/= 22 years of age
Key exclusion criteria (7 listed)
- The subject has current acute coronary syndrome, decompensated heart failure or stroke
- The subject has received any prior cardiac interventions or surgical therapeutic procedures relating to cardiac abnormalities: valve replacement, pacemaker implantation, coronary artery bypass grafting (CABG), heart transplant, ablation, coronary stent placement, etc.
- Conventional ECG results indicating a lack of sinus rhythm and/or any other contraindicated rhythm abnormalities, including: active atrial fibrillation or atrial flutter, left anterior fascicular block, left and/or right bundle branch block
- The subject is pregnant at the time of the study testing
- The subject has chest deformities that interfere with accurate measurement of ECG (either conventional or wavECG)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MyoVista wavECG TestThe MyoVista wavECG is a standard 12-Lead high-performance, multi-channel resting interpretive electrocardiograph providing both a Glasgow Interpretive Analysis and unique MyoVista wavECG Information. | Device | At Risk Echo Referrals |
Primary outcome
Sensitivity and Specificity
Time frame: Baseline
Sensitivity and specificity of the MyoVista for the classification of Low e' from echocardiogram where a "positive" includes Positive and Highly Positive MyoVista Device outcomes.
1 secondary outcome
Sensitivity and Specificity
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Partho Sengupta, MD principal investigator
Robert Wood Johnson University Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Disease, run by Heart Test Laboratories, Inc. at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and Specificity (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2023; AzTrials last refreshed its copy on 29 Oct 2026.